The fields of medicine and surgical medicine involve methods and structures useful for connecting tissue, and for connecting surgical items such as implants to tissue. Medical and surgical sutures are ubiquitous for these purposes. These can take the form of a natural or synthetic thread or other fibrous or filamentary structure that is passed through tissue, optionally passed through or around an implant or other surgical item, and then tied off to secure the tissue and tissue, or tissue and surgical item, in place.
The use of sutures is not perfect or even highly suitable for all surgical and medical procedures. For example, sutures are best tied by a surgeon or other medical professional manually, with assistance of tools such as a suture passing needle, needle driver, knot pusher, forceps, and other surgical tools. This works well when the surgeon or medical professional has open access to the site of the suture, but less well when the suture must be tied in a constrained location or through tight access to the location. For those situations, a surgeon may experience difficulty placing the suture at its most effective or desired location, and tying the suture to best secure tissue to tissue or tissue to an implant.
Potential replacements for sutures have long been the subject of product research. Over time, countless examples of non-suture suture-replacement devices, related delivery tools, and related methods, have been developed and tried in efforts to replace the ubiquitous suture with an easier to use device. Examples include surgical staples and biologic adhesives useful to hold tissue to tissue or tissue to an implant, and soft tissue anchors useful to secure surgical implants directly at patient tissue. Many of these have been used in particular applications that require placement of a suture at a difficult-to-reach surgical site or through a tight or deep surgical access path. Examples of these types of applications include surgical procedures that are performed laparoscopically and surgical procedures that are performed transvaginally in a female patient or through a comparable medial or perineal tissue surgical access incision in a male patient. Many of these procedures are performed for treating a pelvic health condition such as prolapse or incontinence.
Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), conditions of the pelvic floor such as levator avulsion or prolapse, and hernias.
Incontinence includes all various forms of anal (fecal) and urinary incontinence in a male or female. Vaginal prolapse in a female patient can be in the form of a cystocele, rectocele, enterocele, or vaginal vault prolapse, some of which can occur in combination with anal or urinary incontinence. In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times. Sacralcolpopexy (SCP) procedures are considered to be especially efficacious methods for treating vaginal vault prolapse. Various methods of placing slings or other implants for treating urinary or fecal continence are commonly used.
Still, there ongoing research and development of new and effective methods of surgically connecting tissue or surgically placing supportive implants for treating pelvic conditions in male and female patients, such as hernias, vaginal prolapse, incontinence, and other conditions affecting pelvic tissue and function. More generally, continuing interest exists for suture replacements in general surgical procedures in both humans and animals (i.e., in veterinary medicine), and in specific surgical specialties (e.g., plastic surgery).